Director, Clinical Quality Assurance (Gene Therapy)

Director Of Clinical Quality Assurance

At Insmed, every moment and every patient counts and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role :

Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical Operations and Medical Departments. This role provides support and promotes collaboration internally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.

What You'll Do :

• Establish and maintain a risk-based and scientific-based quality system to support GCP.
• Oversee regulatory agency inspections and vendor audits.
• Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are conducted, and reports written according to SOPs and regulations.
• Oversee GCP activities (including internal or external audit observations and development of adverse trends) to ensure patient safety and data integrity.
• Supports strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.
• Supports the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality Assurance.
• Full understanding of and practical experience establishing and fostering compliance with ICH E6 Guideline for Good Clinical Practice.
• Provide support and coaching to other staff members to develop additional quality and auditing resources.
• Manage quality documentation in Veeva. (SOPs, CAPAs, Deviations, etc.)

Who You Are :

Travel : Up to 15% flexible self-directed travel, both domestic and / or international.

Pay Range : $171,000.00-239,667.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our missionintentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include :

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.